MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION HEAD M 36/0 TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Numbness (2415); Decreased Sensitivity (2683)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Medical product: item#:00-6305-060-36; lot#:64052188; name: liner standard 3.5 mm offset 36 mm i.D.For use with 60 mm o.D.Shell; therapy date: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient had recurrent dislocations which were treated by closed reduction procedure.

Manufacturer Narrative

1.Event description: it was reported that the patient experienced pain, numbness, altered sensation, foot drop, and 2 dislocations with reductions.Harm: s3 - dislocation, s3 - pain or ache, moderate hazardous situation: properly placed implants do not accurately restore the patient's kinematics and/or anatomy.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- surgical report: review of the provided medical records identified that the patient reported numbness, intermittent pain, and lacks sensation on (b)(6) 2020.The patient then was seen in the emergency department on (b)(6) 2020 for a dislocation with a successful closed reduction.The patient then had an open reduction performed due to dislocation on (b)(6) 2021.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: document review could not be performed due to unknown product identification.- device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.5.Conclusion: it was reported that the patient experienced pain, numbness, altered sensation, foot drop, and 2 dislocations with reductions.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).As no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer switzerland manufacturing gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer switzerland manufacturing gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient experienced pain, numbness, altered sensation, foot drop, and 2 dislocations with reductions.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Surgical report: review of the provided medical records identified that the patient reported numbness, intermittent pain, and lacks sensation on (b)(6) 2020.The patient then was seen in the emergency department on (b)(6) 2020 for a dislocation with a successful closed reduction.The patient then had an open reduction performed due to dislocation on (b)(6) 2021.Finally, patient underwent revision surgery to explant ceramic head on (b)(6) 2021.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Conclusion: it was reported that the patient experienced pain, numbness, altered sensation, foot drop, and 2 dislocations with reductions.Finally, patient underwent revision surgery to explant ceramic head on (b)(6) 2021.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX OPTION HEAD M 36/0 TAPER 12/14
• Type of Device: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12638045
• MDR Text Key: 276555539
• Report Number: 0009613350-2021-00530
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430525
• UDI-Public: 00889024430525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 12/23/2021
• Supplement Dates FDA Received: 12/15/2021; 12/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 149 KG